Kerr Maxcem Elite — Class II medical device recall Z-1076-2013
Terminated recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, reported 2013-04-17, distributed nationwide. Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing th
| Recall number | Z-1076-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA, United States |
| Recall initiated | 2013-02-22 |
| Classified | 2013-04-09 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2014-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, HK, HR, HU, IE, IL, IN, JP, LB, LU, LV, MX, MY, NL, NO, PA, PL, PT, RO, RS, SE, SG, SI, TH, TR, UA, VN, ZA |
| Quantity | 40,819 kits |
| Lot numbers | 34417, 34418 |
| Model numbers | 34059, 34060, 34417, 4728840, 4728844, 4728935, 4728936, 4730842, 4732144, 4735257, 4735546, 4745082, 4748934, 4756504, 4756505, CLEAR-4628189, WHITE-4705713 |
Product
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Reason for recall
Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1076-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.